Active — Not RecruitingNot Applicable

Early Safety and Clinical Efficacy of Mitral Allograft in Tricuspid Surgery

Russia30 participantsStarted 2021-09-29

Plain-language summary

The aim of the study is to evaluate early safety and clinical efficacy of mitral allografts in tricuspid valve replacement for primary tricuspid valve diseases.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with primary tricuspid valve disease and/or tricuspid bioprosthetic failure scheduled for tricuspid valve intervention. * Intraoperative findings suggested for tricuspid valve replacement rather than repair. Exclusion Criteria: * Pregnancy * Confirmed active drug addiction * Progressive HIV-infection * HIV-infected patients with CD4-cells count less than 250 * Patients with secondary tricuspid valve pathology (left-sided valve disease) * LV Ejection fraction less than 50%

What they're measuring

Mortality (all cause and valve-related)

Timeframe: 30-day period

Trial details

NCT IDNCT06196684

SponsorChelyabinsk Regional Clinical Hospital

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2026-09-29

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